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FDAApril 5, 2023device

DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

What to do

FDA enforcement status: Ongoing

Brands named

smiths medical asdsmithssmiths medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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